FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM
K Number: K021103
·
Decision Apr 24, 2002
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
49
Applicant Total
135
Review Days
19
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Basic Information
- Device Name
- MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM
- K Number
- K021103
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Zeus Scientific, Inc.
- Date Received
- April 5, 2002
- Decision Date
- April 24, 2002
- Product Code
- LKJ
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LKJ | Antinuclear Antibody, Antigen, Control | FDA class 2 | Immunology |
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